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A drug, MT-401 (zedenoleucel), to treat acute myeloid leukemia (AML)


18 and older

Phase 2

18 Locations


Clinical Trial Goal

To find out if zedenoleucel is safe and works well to treat AML

You may be able to join this trial if you:

  • Are 18 years old or older
  • Have AML and 1 of the following:
    • Are planning to have an allogeneic (cells from a donor) blood or marrow transplant (BMT) or
    • The AML has come back (relapse or minimal residual disease) after having an allogeneic BMT
  • Have not had more than 1 allogeneic BMT
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details

Zedenoleucel is made from T cells (a type of immune cell) from the same donor used for the BMT. Doctors think that T cells treated in a lab to become tumor-associated antigen (TAA)-specific T cells may help your body to find and destroy leukemia cells.

For individuals who have not yet had an allogeneic BMT, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in. 
  • Group 1 – Zedenoleucel
  • Group 2 – Standard treatment

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
If you're in Group 1, you'll get zedenoleucel, given as an intravenous (IV) infusion about 3 months after allogeneic BMT or when the clinical trial doctors think it's best for your health.

If you're in Group 2, you'll get standard treatment after allogeneic BMT. If the AML relapses or MRD is detected, you can go into Group 1.

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.

The Food and Drug Administration (FDA) has not yet approved zedenoleucel.


Gerald Garrett, 713.400.6400,

Mythilli Koneru, MD, PhD, 713.400.6400,


University of Alabama at BirminghamRecruiting

Birmingham, Alabama

City of Hope National Medical CenterRecruiting

Duarte, California
Shukaib Arslan, MD, 877-467-3411,

Moores Cancer Center at University of Californa San DiegoRecruiting

La Jolla, California
Michelle Padilla, 858-822-5223,

UCLA Department of MedicineRecruiting

Los Angeles, California
Vladimir kustanovich, 310-206-5756,

Yale Cancer CenterRecruiting

New Haven, Connecticut
Alexandra Dormal, 203-737-4839,

Mayo Clinical Cancer Center-FloridaRecruiting

Jacksonville, Florida
Tammy Bicknese, 507-266-6841,

Moffitt Cancer CenterRecruiting

Tampa, Florida

Winship Cancer Institute of Emory UniversityRecruiting

Atlanta, Georgia

University of ChicagoRecruiting

Chicago, Illinois
Hongtao Liu, MD, 773-702-0589,

University of Iowa Hospitals & ClinicsRecruiting

Iowa City, Iowa

Mayo Clinic Cancer Center-RochesterRecruiting

Rochester, Minnesota
Mary Glatzmaier, 507-422-4269,

John Theurer Cancer Center at Hackensack UMCRecruiting

Hackensack, New Jersey
Andrew McConnel, 551-996-5949,

Memorial Sloan Kettering Cancer CenterRecruiting

New York, New York

Montefiore Medical CenterRecruiting

Bronx, New York

Weill Cornell Medicine | NewYork-PresbyterianRecruiting

New York, New York
Danielle Guarneri, 212-746-0974,

Cleveland Clinic Taussig Cancer CenterRecruiting

Cleveland, Ohio
Nicolette Steigerwald, 440-773-4810,

Baylor College of MedicineRecruiting

Houston, Texas
Catherine Robertson, 832-824-5494,

MD Anderson Cancer CenterRecruiting

Houston, Texas
Jessica M McCarty, 713-745-5228, record

NCT04511130. First posted on 8/13/20

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